Medline recalls convenience kits for central line inserts and LVAD drivelines due to potential sterility assurance level impacts from calibration issues in sterilization packaging.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline is recalling specific convenience kits used in medical settings because calibration problems during sterilization could compromise their sterility. This means the kits might not be safe for use as intended, risking infections for patients.
The sterilization and packaging cycles for these kits had calibration issues that could lower the sterility assurance level. This means the kits might not be properly sterilized, increasing the risk of infection for patients during medical procedures.
Healthcare professionals and medical facilities that use these convenience kits for central line procedures or LVAD (left ventricular assist device) treatments. Patients receiving care with these kits are at risk of infection.
Check for model numbers CVI3780 (central line universal insert), DM1035 (LVAD driveline tray), or DYKMBNDL43 (kit surgical onc insert) with specific lot numbers listed in the recall notice.
Identify the model number and lot number on the product to confirm if it is recalled.
Medline identified calibration issues in the sterilization and packaging cycles that could impact the sterility assurance level of the kits.
Central line universal inserts (model CVI3780), LVAD driveline trays (model DM1035), and kit surgical onc inserts (model DYKMBNDL43) with specific lot numbers listed in the recall.
The recall does not require immediate discontinuation; however, affected products should be checked and handled according to the provided details.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2103-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2103-2026 from Medline. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
